To understand the mechanism of action of OA for the treatment of de novo, severely calcified coronary lesions prior to stent placement using optical coherence tomography (OCT) and to assess stent expansion, based on OCT derived minimal stent area (…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is proportion of patients with stent
expansion defined by OCT derived minimal stent area (MSA) >= 5.5mm².
Secondary outcome
Secondary endpoint
Divided into three subgroups, clinical, intracoronary imaging and angiographic
endpoints.
Clinical endpoints (measured at discharge, 30 days and 12 months):
• Procedural success, defined as successful stent delivery with:
o Final Core Lab defined Thrombolysis in Myocardial Infarction (TIMI) flow of
III.
o Angiographic in-stent diameter stenosis (DS) <=20%.
o Absence of in-hospital major adverse cardiac and cerebrovascular events
(MACCE, consisting of all-cause death, spontaneous myocardial infarction (MI),
target vessel revascularization (TVR), stroke).
• Target vessel failure (TVF, consisting of cardiac death, target vessel
spontaneous MI, and TVR).
• Major adverse cardiac events (MACE, consisting of all-cause death,
spontaneous MI, and repeat revascularization).
• Individual components of MACE and TVF.
• Incidence of periprocedural MI:
o Type 4a (4th universal def).
• Major intraprocedural complications including type C-F dissections,
perforations, slow flow or no reflow, thrombus and major side branch occlusion
(>2mm).
• Probable and definite stent thrombosis
Intracoronary imaging endpoints (OCT)
• Final MSA
• Percentage of stent expansion
• Percentage of lumen area gain post OA and post stenting
• Minimal lumen area (MLA) post OA and post stenting
• Number of calcium fractures
• Number of calcium fractures based on calcium thickness post OA
• Incidence of OCT defined hematomas post OA
• Incidence and quantification of dissections post OA
• Number of calcified nodules modified post OA
Angiographic endpoints (Core Lab Assessed):
• Lesion length, diameter percentage of stenosis, reference vessel diameter
• In-stent and in-segment DS
• In-stent and in-segment minimal lumen diameter (MLD)
• In-stent and in-segment acute gain
Background summary
The Diamondback 360° Coronary Orbital Atherectomy System (OAS) (Cardiovascular
Systems Inc., St. Paul,MN,USA) is a percutaneous device indicated to modify
calcified lesion in order to facilitate stent delivery in patients with
severely calcified coronary artery disease (CAD). As of to date, detailed
sequential intravascular imaging data unraveling the exact calcium modifying
effect of orbital atherectomy (OA) prior to stent placement in vivo, are
lacking.
Study objective
To understand the mechanism of action of OA for the treatment of de novo,
severely calcified coronary lesions prior to stent placement using optical
coherence tomography (OCT) and to assess stent expansion, based on OCT derived
minimal stent area (MSA).
Study design
International, multicenter, prospective and observational single arm registry
Study burden and risks
Patients with severely calcified significant coronary lesions are at high risk
of myocardial infarction and sudden death if left untreated. Treating such
lesions have small procedural risks from the use of specified devices. Efficacy
and safety of OAS was proved in the ORBIT I and II trials. Both OAS and OCT
devices are already widely used, OAS facilitates stent delivery in severely
calcified lesions and OCT facilitates procedure overall to optimize stenting
result
Patients will be asked for a telephone contact at 30 days and clinic visit and
12 months.
Participation contributes to expand the knowledge base for the mechanism of
action of the OAS which may assist physicians in their choice of treating any
future patients, enhance the ability of use of the operator and by extension
improve patient outcomes.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
1. De novo significant native coronary artery lesion.
2. The target lesion must have evidence of severe calcification:
a. Presence of radiopacities noted without cardiac motion prior to contrast
injection involving both sides of the arterial wall with calcification length
of at least 15 mm and extend partially into the target lesion.
b. Presence of >=270° of calcium or lumen protruding calcified nodule(s) at >1
cross section assessed by OCT.
3. The target vessel reference diameter >= 2.5 mm and <= 4.0 mm and lesion must
not exceed 40 mm in length.
4. Age > 18 years or minimum age as required by local regulations
Exclusion criteria
1. Left main disease
2. Prior stenting of the target vessel.
3. Target lesion has thrombus or dissection.
4. Known LVEF <=25%.
5. Diagnosed with chronic renal failure (GFR<30ml/min)
6. Confirmed pregnancy.
7. Life expectancy <12months.
8. Age<18y.
9. Coronary anatomy that prevent delivery of OCT catheter
10. Known allergy to soybean oil, egg yolk phospholipids, glycerin or sodium
hydroxide
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81318.078.22 |